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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 10, 2007 | ||||
| Last Updated Date | November 5, 2009 | ||||
| Start Date ICMJE | December 2007 | ||||
| Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Cognitive and Functional [ Time Frame: 18 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00574132 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Cognitive and Global [ Time Frame: 18 months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Non-Carrier) | ||||
| Official Title ICMJE | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Trial of Bapineuzumab (AAB-001, ELN115727) In Patients With Mild to Moderate Alzheimer's Disease Who Are Apolipoprotein E4 Non- Carriers. | ||||
| Brief Summary | This is a multicenter, double-blind, placebo controlled, randomized, outpatient multiple dose study in male and female patients ages 50 to less than 89 years with mild to moderate AD. Approximately 200 study sites in the US and Canada will be involved. Patients will be randomized to receive either bapineuzumab or placebo. Each patient's participation will last approximately 1.5 years. Bapineuzumab is a humanized monoclonal antibody, which binds to and clears beta amyloid peptide, and is designed to provide antibodies to beta amyloid directly to the patient. |
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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment | ||||
| Condition ICMJE | Alzheimer's Disease | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 1250 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 50 Years to 88 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States, Canada | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00574132 | ||||
| Responsible Party | VP Clinical Development, JANSSEN Alzheimer Immunotherapy Research & Development, LLC | ||||
| Study ID Numbers ICMJE | ELN115727-301 | ||||
| Study Sponsor ICMJE | JANSSEN Alzheimer Immunotherapy Research & Development, LLC | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE | |||||
| Information Provided By | JANSSEN Alzheimer Immunotherapy Research & Development, LLC | ||||
| Verification Date | November 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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